MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 18GAX8CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00818

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint reports: "i did not have any difficulty accessing vessel; however, as i was trying to thread the guidewire, i felt resistance.I pulled the guidewire back in original position and rechecked my tip placement with ultrasound.Tip showed in middle of vessel so i went to thread guidewire again and had same difficulty.I then decided to pull the entire catheter out and was going to attempt again until i realized that the entire catheter was not there.It was an 18g x 8cm endurance and only about 6.5cm of the catheter came out intact." the physician and vascular were notified.It was reported the catheter tip is stuck in the patient and the patient will have to have it surgically removed.Additional information recevied 29-aug reports the patient is end of life so the catheter is not going to be removed.

Manufacturer Narrative

(b)(4).The customer returned one photo for evaluation.The complaint of a catheter cut/torn was able to be confirmed.The customer also returned one, opened endurance kit for evaluation.Signs of use were observed inside the catheter body.The catheter was completely deployed off the needle cannula.Visual inspection of the complaint sample endurance catheter revealed the body was separated towards the distal end.The separation point was smooth but offset.The separated portion of the catheter was not returned by the customer.No other defects or anomalies were observed.It was also noted that the guide wire was deployed out of the cannula and was kinked; however, the customer reiterated that no new complaint was needed to address this issue.The point of separation on the catheter body measured 71mm from the juncture hub.This indicates that approximately 14mm of the catheter body was separated and not returned for analysis (per the catheter product drawing).The catheter body outer diameter measured.049", which is within the specification limits of.049"-.053" per the catheter extrusion product drawing.The catheter body inner diameter (at the point of separation measured.039"), which is within the specification limits of.037"-.041" per the catheter extrusion product drawing.The catheter length could not be officially confirmed without the separated portion also returned for analysis.A lab inventory syringe filled with water was attached to the catheter side arm and flushed.Water was observed exiting the point of separation on the catheter body.No leaks were observed.Performed per ifu statement, "remove syringe and attach needleless connector or stopcock and flush per institutional policies and procedures".The catheter body was bent is several locations to determine of the catheter body was brittle.The catheter body was able to be bent as intended.No separations were encountered due to brittleness.The sample was sent to the material testing lab in wyomissing for additional analysis.This testing confirmed that the catheter body shows no signs of material weakness.A device history record review was performed based on a potential lot identified from sales history, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not raise the catheter beyond 90 relative to the skin to avoid catheter kinking and damage".The ifu also states, "return catheter to its original position making sure juncture hub and catheter release tab fit tightly together and the distal tip of catheter is retracted past needle bevel".The report of an endurance catheter separated was confirmed through complaint investigation.Visual analysis revealed that the catheter body was separated towards the distal end.Microscopic examination revealed that the edges of the separation were smooth but offset.The separated portion was not returned for analysis so the catheter length could not be verified; however, the catheter inner and outer diameters were within specification.The catheter also met all relevant functional requirements, and a device history record review was performed based on sales history with no relevant findings.Based on the customer report, the sample received, and the comments from r & d, the root cause for this complaint is likely related to unintentional use error.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint reports: "i did not have any difficulty accessing vessel; however, as i was trying to thread the guidewire, i felt resistance.I pulled the guidewire back in original position and rechecked my tip placement with ultrasound.Tip showed in middle of vessel so i went to thread guidewire again and had same difficulty.I then decided to pull the entire catheter out and was going to attempt again until i realized that the entire catheter was not there.It was an 18g x 8cm endurance and only about 6.5cm of the catheter came out intact." the physician and vascular were notified.It was reported the catheter tip is stuck in the patient and the patient will have to have it surgically removed.Additional information recevied 29-aug reports the patient is end of life so the catheter is not going to be removed.

Event Description

Customer complaint reports: "i did not have any difficulty accessing vessel; however, as i was trying to thread the guidewire, i felt resistance.I pulled the guidewire back in original position and rechecked my tip placement with ultrasound.Tip showed in middle of vessel so i went to thread guidewire again and had same difficulty.I then decided to pull the entire catheter out and was going to attempt again until i realized that the entire catheter was not there.It was an 18g x 8cm endurance and only about 6.5cm of the catheter came out intact." the physician and vascular were notified.It was reported the catheter tip is stuck in the patient and the patient will have to have it surgically removed.Additional information received 29-aug reports the patient is end of life so the catheter is not going to be removed.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of cut endurance catheter was not able to be confirmed by the photo, due to the photo quality.A complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to pressure injection to reduce risk of catheter failure and/or patient complications.Inability to obtain brisk blood return or to flush easily indicates a possible problem with the catheter and catheter should not be used".The ifu also states, "prior to insertion, distal tip of catheter must be fully retracted past needle bevel or catheter tip damage may occur".The customer report of a separated endurance catheter could not be confirmed by visual inspection of the customer supplied photo.Additionally, a full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on sales history, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 18GAX8CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15445295
• MDR Text Key: 300124311
• Report Number: 9680794-2022-00575
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDC-00818
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Patient Outcome(s): Other